Z-0792-2019Class III

BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a...

Name: Z-0792-2019 BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2019-01-02
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2019-01-02 / Terminated

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both... on 2019-01-02. FDA classified it as Class III and gives the reason as "A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0792-2019
Classification: Class III
Status: Terminated
Initiated: 2019-01-02
Posted: 2019-02-01
Terminated: 2021-05-07
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.
Product code: OYE Flow Cytometric Reagents And Accessories.
Reason for recall: A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for research use only.
FDA root cause: Under Investigation by firm
Action: The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated 12/26/2018; telephoned and emailed its consignee on 01/02/2019. BD Service will install the correction. The letter described the product, problem and actions to be taken. The consignees were instructed to: 1. Retain this letter with the instrument records maintained by your facility. 2. Complete the attached Customer Response Form and return to the contact noted so that BD may acknowledge your receipt of this notification via Email: [email protected] Attn: BD Regulatory Compliance. If you require further assistance, please contact: BD Customer/Technical Support; BD Customer Support at 855.236.2772 (prompt 2) for instruments in the United States. For customers outside the US, contact your local BD representative or distributor.
Quantity in commerce: 3 devices
Distribution: US Distribution in MD.
Product codes and lots: UDI: (01)00382906628787(11)180508(21)Z662878000056 serial number: Z662878000056 Work Station SN 2UA80820ZZ UDI: (01)00382906628787(11)180301(21)Z662878000029 serial number: Z662878000029 Work Station SN 2UA80820ZW UDI: (01)00382903389605(11)180315(21)11662382000007 serial number: R662382000007 Work Station SN 2UA8082101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0792-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0792-2019	Class III	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-01

Product code OYE

K170974Class IIBD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company / cleared 2017-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)